CARTITUDE-1 患者与德国注册登记中既往暴露于 PI、Imid 和抗 CD-38 的多发性骨髓瘤患者的校正结局比较

Ciltacabtagene autoleucel (cilta-cel) is a Chimeric antigen receptor T-cell therapy with the potential for long-term disease control in heavily pre-treated patients with relapsed/refractory multiple myeloma (RRMM). As cilta-cel was assessed in the single-arm CARTITUDE-1 clinical trial, we used an external cohort of patients from the Therapie Monitor registry fulfilling the CARTITUDE-1 inclusion criteria to evaluate the effectiveness of cilta-cel for overall survival (OS) and time to next treatment (TTNT) vs. real-world clinical practice. Individual patient data allowed us to adjust the comparisons between both cohorts, using the inverse probability of treatment weighting (IPW; average treatment effect in the treated population (ATT) and overlap population (ATO) weights) and multivariable Cox proportional hazards regression.

Outcomes were compared in intention-to-treat (HR, IPW-ATT: TTNT: 0. 13 (95% CI: 0. 07, 0. 24); OS: 0. 14 (95% CI: 0. 07, 0. 25); IPW-ATO: TTNT: 0. 24 (95% CI: 0. 12, 0. 49); OS: 0. 26 (95% CI: 0. 13, 0. 54)) and modified intention-to-treat (HR, IPW-ATT: TTNT: 0. 24 (95% CI: 0. 09, 0. 67); OS: 0. 26 (95% CI: 0.

08, 0. 84); IPW-ATO: TTNT: 0. 26 (95% CI: 0. 11, 0. 59); OS: 0. 31 (95% CI: 0. 12, 0. 79)) populations. All the comparisons were statistically significant in favor of cilta-cel. These results highlight cilta-cel's potential as a novel, effective treatment to address unmet needs in patients with RRMM.